Registration file validation : New release of checker

The checker currently used within the FAMHP for technical validation of all submitted registration dossiers (MRP/DCP/NAT) concerning medicinal products for human use has been adapted in order to comply with new legislation, NeeS recommendations and ICH specifications. Due to this adaptation it can be stated that the use of the checker is more flexible and will enlarge its use. More details on the adapted checker can be found in the document ‘Checker – Change requests – part II’

New version of checker.


ICH : International Conference on Harmonization

NeeS : Non-eCTD electronic Submission

Last updated on 08/05/2009